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晚期卵巢上皮癌初始治疗中化疗与手术的比较

Chemotherapy versus surgery for initial treatment in advanced ovarian epithelial cancer.

作者信息

Morrison Jo, Haldar Krishnayan, Kehoe Sean, Lawrie Theresa A

机构信息

Department of Obstetrics and Gynaecology, Musgrove Park Hospital, Taunton, UK.

出版信息

Cochrane Database Syst Rev. 2012 Aug 15;2012(8):CD005343. doi: 10.1002/14651858.CD005343.pub3.

Abstract

BACKGROUND

Epithelial ovarian cancer presents at an advanced stage in the majority of women. These women require surgery and chemotherapy for optimal treatment. Conventional treatment is to perform surgery first and then give chemotherapy. However, it is not yet clear whether there are any advantages to using chemotherapy before surgery.

OBJECTIVES

To assess whether there is an advantage to treating women with advanced epithelial ovarian cancer with chemotherapy before cytoreductive surgery (neoadjuvant chemotherapy (NACT)) compared with conventional treatment where chemotherapy follows maximal cytoreductive surgery.

SEARCH METHODS

For the original review we searched, the Cochrane Central Register of Controlled Trials (CENTRAL, Issue 3, 2006), MEDLINE (Silver Platter, from 1966 to 1 Sept 2006), EMBASE via Ovid (from 1980 to 1 Sept 2006), CANCERLIT (from 1966 to 1 Sept 2006), PDQ (search for open and closed trials) and MetaRegister (most current search Sept 2006). For this update randomised controlled trials (RCTs) were identified by searching the Cochrane Central Register of Controlled Trials (CENTRAL, Issue 3, 2011) and the Cochrane Gynaecological Cancer Specialised Register (2011), MEDLINE (August week 1, 2011), EMBASE (to week 31, 2011), PDQ (search for open and closed trials) and MetaRegister (August 2011).

SELECTION CRITERIA

RCTs of women with advanced epithelial ovarian cancer (Federation of International Gynaecologists and Obstetricians (FIGO) stage III/IV) who were randomly allocated to treatment groups that compared platinum-based chemotherapy before cytoreductive surgery with platinum-based chemotherapy following cytoreductive surgery.

DATA COLLECTION AND ANALYSIS

Data were extracted by two review authors independently, and the quality of included trials was assessed by two review authors independently.

MAIN RESULTS

One high-quality RCT met the inclusion criteria. This multicentre trial randomised 718 women with stage IIIc/IV ovarian cancer to NACT followed by interval debulking surgery (IDS) or primary debulking surgery (PDS) followed by chemotherapy. There were no significant differences between the study groups with regard to overall survival (OS) (670 women; HR 0.98; 95% CI 0.82 to 1.18) or progression-free survival (PFS) (670 women; HR 1.01; 95% CI 0.86 to 1.17).Significant differences occurred between the NACT and PDS groups with regard to some surgically related serious adverse effects (SAE grade 3/4) including haemorrhage (12 in NACT group vs 23 in PDS group; RR 0.50; 95% CI 0.25 to 0.99), venous thromboembolism (none in NACT group vs eight in PDS group; RR 0.06; 95% CI 0 to 0.98) and infection (five in NACT group vs 25 in PDS group; RR 0.19; 95% CI 0.07 to 0.50). Quality of life (QoL) was reported to be similar for the NACT and PDS groups.Three ongoing RCTs were also identified.

AUTHORS' CONCLUSIONS: We consider the use of NACT in women with stage IIIc/IV ovarian cancer to be a reasonable alternative to PDS, particularly in bulky disease. With regard to selecting who will benefit from NACT, treatment should be tailored to the patient and should take into account resectability, age, histology, stage and performance status. These results cannot be generalised to women with stage IIIa and IIIb ovarian cancer; in these women, PDS is the standard. We await the results of three ongoing trials, which may change these conclusions.

摘要

背景

大多数上皮性卵巢癌女性患者就诊时已处于晚期。这些女性需要手术和化疗以获得最佳治疗效果。传统治疗方法是先进行手术,然后进行化疗。然而,术前使用化疗是否具有任何优势尚不清楚。

目的

评估与在最大程度肿瘤细胞减灭术后进行化疗的传统治疗方法相比,对晚期上皮性卵巢癌女性患者在肿瘤细胞减灭手术(新辅助化疗(NACT))前进行化疗是否具有优势。

检索方法

对于原始综述,我们检索了Cochrane对照试验中心注册库(CENTRAL,2006年第3期)、MEDLINE(Silver Platter,1966年至2006年9月1日)、通过Ovid检索的EMBASE(1980年至2006年9月1日)、CANCERLIT(1966年至2006年9月1日)、PDQ(检索开放和封闭试验)以及MetaRegister(2006年9月最新检索)。对于本次更新,通过检索Cochrane对照试验中心注册库(CENTRAL,2011年第3期)和Cochrane妇科癌症专业注册库(2011年)、MEDLINE(2011年8月第1周)、EMBASE(至2011年第31周)、PDQ(检索开放和封闭试验)以及MetaRegister(2011年8月)来识别随机对照试验(RCT)。

选择标准

晚期上皮性卵巢癌(国际妇产科联合会(FIGO)III/IV期)女性患者的RCT,这些患者被随机分配至治疗组,比较肿瘤细胞减灭术前基于铂类的化疗与肿瘤细胞减灭术后基于铂类的化疗。

数据收集与分析

由两位综述作者独立提取数据,两位综述作者独立评估纳入试验的质量。

主要结果

一项高质量RCT符合纳入标准。这项多中心试验将718例IIIc/IV期卵巢癌女性患者随机分为接受新辅助化疗后行间隔肿瘤细胞减灭术(IDS)组或先行初次肿瘤细胞减灭术(PDS)后行化疗组。研究组在总生存期(OS)(670例女性;风险比(HR)0.98;95%置信区间(CI)0.82至l.18)或无进展生存期(PFS)(670例女性;HR 1.01;95%CI 0.86至1.17)方面无显著差异。新辅助化疗组和初次肿瘤细胞减灭术组在一些与手术相关的严重不良反应(3/4级严重不良反应)方面存在显著差异,包括出血(新辅助化疗组12例 vs 初次肿瘤细胞减灭术组23例;RR 0.50;95%CI 0.25至0.99)、静脉血栓栓塞(新辅助化疗组无 vs 初次肿瘤细胞减灭术组8例;RR 0.06;95%CI 0至0.98)和感染(新辅助化疗组5例 vs 初次肿瘤细胞减灭术组25例;RR 0.19;%CI 0.07至0.50)。据报道,新辅助化疗组和初次肿瘤细胞减灭术组的生活质量(QoL)相似。还识别出三项正在进行的RCT。

作者结论

我们认为对IIIc/IV期卵巢癌女性患者使用新辅助化疗是初次肿瘤细胞减灭术的合理替代方案,尤其是对于体积较大的肿瘤。关于选择哪些患者将从新辅助化疗中获益,治疗应根据患者情况进行调整,并应考虑可切除性、年龄、组织学类型、分期和体能状态。这些结果不能推广至IIIa期和IIIb期卵巢癌女性患者;对于这些女性患者,初次肿瘤细胞减灭术是标准治疗方法。我们等待三项正在进行的试验的结果,这可能会改变这些结论。

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